pancreatic cancer
Conditions
Interventions
Anlotinib combined with S-1 and immune checkpoint inhibitors group:Treatment with Anlotinib combined with S-1 and immune checkpoint inhibitors
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years, both sexes. (2) Locally advanced, unresectable, recurrent or metastatic pancreatic cancer diagnosed by pathological histology or cytology. (3) Progression after receiving at least one line of chemotherapy or discontinuation of treatment due to intolerance of first-line chemotherapy. (4) Has at least one evaluable lesion (Resist 1.1 criteria). (5) Expected survival of 3 months or more. (6) ECOG score 0-1. (7) Meet the indications and basic requirements for chemotherapy, including basically normal peripheral blood picture, no significant abnormalities in cardiac, hepatic and renal functions, basically normal ECG, and no unhealed trauma on the organism; laboratory indicators must meet the following requirements: peripheral blood picture: white blood cells (WBC) = 3.5×109/L, platelets (PLT) = 80×109/L, haemoglobin (Hb) = 90 g/L. Renal function: serum creatinine (Cr) = 2.0 x upper limit of normal value (UNL), blood urea nitrogen (BUN) = 2.5 x UNL. liver function: blood bilirubin (BIL) = 2.5 x UNL, blood transaminases (ALT/AST) = 2.5 x UNL. (8) Have good compliance. (9) Have fully understood this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Previous use of anti-angiogenic drugs or PD-1 and PD-L1 monoclonal antibodies. (2) Persons with severe cardiac disease or medical history (angina pectoris requiring medication, intractable hypertension, congestive heart failure, myocardial infarction, high-risk uncontrollable arrhythmias, heart valve disease). (3) The presence of intestinal obstruction, inflammation, unhealed wounds, ulcers, fistulas or bleeding disorders (4) Those who are unable to swallow tablets normally or have abnormal gastrointestinal function which, in the judgment of the investigator, may interfere with the absorption of the drug. (5) Those with hypertension that is not well controlled with antihypertensive medication (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg; (6) Those with previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, mechanized pneumonia, drug-induced pneumonia, or screening-phase CT showing active pneumonia. (7) Persons with abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), with a bleeding tendency, or who are receiving thrombolytic or anticoagulant therapy, are permitted to receive low-dose low molecular heparin or oral aspirin for prophylactic anticoagulation. (8) Any bleeding event with a severity rating of 2 or more on the CTCAE 5.0 scale within 4 weeks prior to administration. (9) Active or uncontrolled serious infection (= CTC AE grade 2 infection). (10) Urine routine showing urine protein >2+ or 24-hour urine protein quantification >1g. (11) Active, known or suspected history of autoimmune disease. (12) Other antineoplastic therapy received within 4 weeks prior to enrolment or toxicity of previous antineoplastic therapy not recovered to grade 0-1. (13) Use of antibiotics or other immunosuppressive agents within 2 weeks prior to the first dose. (14) Hypertension, diabetes mellitus, coronary artery disease, abnormal thyroid function, poorly controlled by medication. (15) Arterial/venous thrombotic events such as cerebrovascular accidents (including temporary ischaemic attacks, cerebral haemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism that occurred within 6 months prior to study drug administration (16) Having received a live vaccine 4 weeks prior to dosing. (17) Persons with a history of severe allergy to chimeric or humanized antibodies or fusion proteins. (18) History of HIV, viral hepatitis with viral count above the lower limit of detection, active tuberculosis, or active infection 2 weeks prior to the first dose. (19) Coexistence of other malignancies. (20) Incomplete healing of major surgical wounds. (21) Pregnant or breastfeeding, fertile but unwilling to accept effective contraception (22) Presence of a physical examination or laboratory abnormality that would interfere with this clinical study. (23) Other conditions which, in the opinion of the investigator, make participation in this study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Overall Survival;Progression Free Survival;Safety; | — |
Countries
China
Contacts
Public Contactzhang mei
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed